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Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise (AMPLITUDE-M)

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ClinicalTrials.gov Identifier: NCT03353350
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE November 21, 2017
First Posted Date  ICMJE November 27, 2017
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE December 5, 2017
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
Change in glycated hemoglobin (HbA1c) (%) [ Time Frame: Baseline to Week 30 ]
Change from Baseline to Week 30 in HbA1c
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
Change in glycated hemoglobin (HbA1c) (%) [ Time Frame: Baseline to Week 30 ]
Change from Baseline to Week 30 in HbA1c (%)
Change History Complete list of historical versions of study NCT03353350 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
  • Change in HbA1c (%) [ Time Frame: Baseline to Week 56 ]
    Change from Baseline to Week 56 in HbA1c
  • Change in fasting plasma glucose (FPG) [ Time Frame: Baseline to Week 30 ]
    Change from Baseline to Week 30 in FPG
  • HbA1c <7% [ Time Frame: Week 30 ]
    Number of participants with HbA1c <7.0% at Week 30
  • Change in body weight [ Time Frame: Baseline to Week 30, Baseline to Week 56 ]
    Change from Baseline to Week 30 and to Week 56 in body weight
  • Hypoglycemic participants [ Time Frame: Baseline to Week 56 ]
    Number of participants with at least 1 hypoglycemic event during treatment period
  • Hypoglycemic events [ Time Frame: Baseline to Week 56 ]
    Number of hypoglycemic events per participant-year during treatment period
  • Adverse Events (AEs) [ Time Frame: Baseline to Week 56 ]
    Number of participants with AEs
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • Change in HbA1c (%) [ Time Frame: Baseline to Week 56 ]
    Change from Baseline to Week 56 in HbA1c (%)
  • Change in fasting plasma glucose (FPG) [ Time Frame: Baseline to Week 30, Week 56 ]
    Change from Baseline to Week 30 and to Week 56 in FPG
  • Change in 7-point self-monitored plasma glucose (SMPG) profile [ Time Frame: Baseline to Week 30, Week 56 ]
    Change from Baseline to Week 30 and to Week 56 in 7-point SMPG profiles (24-hour profile, mean 24-hour SMPG, average pre breakfast SMPG, prandial glucose excursions)
  • HbA1c <7% [ Time Frame: Week 30, Week 56 ]
    Percentage of patients with HbA1c <7.0% at Week 30 and Week 56
  • Rescue therapy [ Time Frame: Week 30, Week 56 ]
    Percentage of patients starting Rescue therapy during the treatment period until Weeks 30 and 56
  • Time to rescue therapy [ Time Frame: Week 56 ]
    Time to initiation of rescue therapy
  • Change in body weight [ Time Frame: Baseline to Week 30, Week 56 ]
    Change from Baseline to Week 30 and to Week 56 in body weight
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Official Title  ICMJE A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Brief Summary

Primary Objective:

To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise.

Secondary Objectives:

  • To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on glycemic control
  • To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on body weight
  • To evaluate the safety of once-weekly injection of efpeglenatide
Detailed Description Study duration per participant is approximately 65 weeks, including a 3-week screening period, 30 weeks core treatment period, 26 weeks extension treatment period, and 6 weeks safety follow up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: efpeglenatide (SAR439977)

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • Drug: placebo

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

Study Arms  ICMJE
  • Experimental: Efpeglenatide low dose
    Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks
    Intervention: Drug: efpeglenatide (SAR439977)
  • Experimental: Efpeglenatide middle dose
    Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
    Intervention: Drug: efpeglenatide (SAR439977)
  • Experimental: Efpeglenatide high dose
    Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
    Intervention: Drug: efpeglenatide (SAR439977)
  • Placebo Comparator: Placebo
    Matching placebo (Prefilled syringe) administered once weekly for 56 weeks
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2017)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Participants must be at least 18 years of age at the time of signing the informed consent.
  • Participants with T2DM, and treated with diet and exercise.
  • Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory at Screening.

Exclusion criteria:

  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease within 6 months prior to Screening or history of surgery affecting gastric emptying.
  • History of pancreatitis (unless pancreatitis was related to gallstone and cholecystectomy has been performed) and pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, and pancreatectomy.
  • Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions that predisposes to MTC (eg multiple endocrine neoplasia syndromes).
  • Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months of screening) or planned: intravitreal injections or laser or vitrectomy surgery.
  • Body weight change of ≥5 kg within the last 3 months prior to Screening.
  • Systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at Randomization.
  • End-stage renal disease as defined by estimated glomerular filtration rate (eGFR , by Modification of Diet in Renal Disease [MDRD]) of <15 mL/min/1.73 m2.
  • Laboratory findings at the Screening Visit:
  • Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) >3 times the upper limit of the normal (ULN ) or total bilirubin >1.5 times the ULN (except in case of documented Gilbert's syndrome).
  • Amylase and/or lipase: >3 times the ULN laboratory range.
  • Calcitonin ≥5.9 pmol/L (20 pg/mL).
  • Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to Screening, or planned during study period.
  • History of drug or alcohol abuse within 6 months prior to the time of Screening.
  • Pregnant (demonstrated by serum pregnancy test at Screening) or breast-feeding women.
  • Women of childbearing potential not willing to use highly effective method(s) of birth control during the study period and for at least 5 weeks after the last dose of study intervention.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com
Listed Location Countries  ICMJE Germany,   Poland,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03353350
Other Study ID Numbers  ICMJE EFC14822
2016-001857-42
U1111-1182-1806 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP